ADOLONTA RETARD 50 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

ADOLONTA RETARD 50 mg prolonged-release tablets

Tramadol, hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Adolonta retard 50 mg is and what it is used for
2. What you need to know before you take Adolonta retard 50 mg
3. How to take Adolonta retard 50 mg
4. Possible side effects
5. Storing Adolonta retard 50 mg
6. Contents of the pack and other information

1. What ADOLONTA RETARD 50 MG is and what it is used for

Tramadol - the active substance of Adolonta retard 50 mg - is an analgesic belonging to the group of opioids that acts on the central nervous system. It relieves pain by acting on specific nerve cells in the spinal cord and brain.

Adolonta retard 50 mg is indicated for the treatment of moderate to severe pain.

2. What you need to know before you take ADOLONTA RETARD 50 MG

Do not take Adolonta retard 50 mg

• If you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6).
• In case of acute intoxication caused by alcohol, sleeping pills, analgesics or psychotropic substances (substances that act on mood and emotions).
• If you are taking monoamine oxidase inhibitors (MAOIs) (certain medicines used to treat depression) or if you have taken them in the last 14 days before starting treatment with Adolonta retard 50 mg (see "Taking Adolonta retard 50 mg with other medicines").
• If you have epilepsy and your seizures are not adequately controlled with treatment.
• For the treatment of withdrawal syndrome.

Warnings and precautions

Consult your doctor before starting to take Adolonta retard 50 mg, if:

• You have disorders of consciousness (if you think you are going to faint).

You are in a state of shock (a sign of this state may be cold sweat).

• You have increased pressure inside the skull (for example, after a head injury or diseases that affect the brain).
• You have difficulty breathing.
• You are epileptic or have seizures, because the risk of these seizures may increase.
• You suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Taking Adolonta retard 50 mg with other medicines").
• You have any liver or kidney disease.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids can make the medicine less effective (the body gets used to it, which is known as pharmacological tolerance). Repeated use of Adolonta retard 50 mg can also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these side effects may be greater with a higher dose and longer use.

Dependence or addiction can cause a feeling of lack of control over the amount of medicine you need to use or how often you need to use it.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent on or addicted to Adolonta retard 50 mg may be greater if:

• You or any member of your family have abused alcohol or experienced dependence on it, prescription medicines, or illegal drugs ("addiction").
• You are a smoker.
• You have had problems with your mood (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following symptoms while using Adolonta retard 50 mg, it could be a sign of dependence or addiction:

• You need to use the medicine for a longer period than indicated by your doctor.
• You need to use a higher dose than recommended.
• You are using the medicine for reasons other than those prescribed, for example, "to feel calm" or "to help you sleep".
• You have made repeated and unsuccessful attempts to stop using the medicine or control its use.
• You feel unwell when you stop using the medicine, and you feel better once you take it again ("withdrawal symptoms").

If you notice any of these signs, consult your doctor to determine the best treatment option for you, when it is appropriate to stop the medicine, and how to do it safely (see section 3, if you interrupt treatment with Adolonta retard 50 mg).

Respiratory disorders related to sleep

Adolonta retard 50 mg contains an active substance that belongs to the group of opioids. Opioids can cause respiratory disorders related to sleep, such as central sleep apnea (shallow breathing or pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen level in the blood).

The risk of experiencing central sleep apnea depends on the dose of opioids. Your doctor may consider reducing the total dose of opioids if you experience central sleep apnea.

There is a weak risk that you may experience a serotonin syndrome that can occur after taking tramadol in combination with certain antidepressants or tramadol alone. Consult a doctor immediately if you present any of the symptoms related to this serious syndrome (see section 4 "Possible side effects").

Seizures have been reported in patients taking tramadol at the recommended dose. The risk may increase when the dose of tramadol exceeds the maximum recommended daily dose (400 mg).

Note that Adolonta retard 50 mg can cause physical and psychological dependence. When Adolonta retard 50 mg is used for a long period, its effect may decrease, so higher doses must be taken (development of tolerance).

In patients with a tendency to abuse medicines or who have a history of drug dependence, treatment with Adolonta retard 50 mg should only be carried out for short periods and under strict medical control.

Also, inform your doctor if any of these problems occur during treatment with Adolonta retard 50 mg or if you have experienced them before.

Tramadol is transformed in the liver by an enzyme. Some people have a variation of this enzyme, and this can affect each person differently. In some people, sufficient pain relief may not be achieved, while others are more likely to experience serious side effects. If you notice any of the following side effects, you must stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise, or vomiting, constipation, loss of appetite.

Tell your doctor if you experience any of the following symptoms while taking Adolonta retard 50 mg:

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These may be indicators of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide if you need to take hormonal supplements.

Taking Adolonta retard 50 mg with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Concomitant treatment with Adolonta retard 50 mg and monoamine oxidase inhibitors (MAOIs) (medicines for the treatment of depression) should be avoided.

Both the analgesic effect of Adolonta retard 50 mg and its duration may be reduced if you take medicines that contain:

• Carbamazepine (for epileptic seizures)
• Ondansetron (medicine to prevent nausea)

Your doctor will tell you if you should take Adolonta retard 50 mg and at what dose.

The risk of side effects increases if you are taking:

• Other analgesics such as morphine and codeine (also when used for cough), and alcohol while taking Adolonta retard 50 mg. It can cause more drowsiness or a feeling of fainting. If this happens, consult your doctor.

Concomitant use of Adolonta retard 50 mg with sedatives or medicines for the treatment of insomnia (such as benzodiazepines) increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, and can be potentially fatal. Due to this, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes this medicine with sedative medicines, they will limit the dose and duration of concomitant treatment.

Tell your doctor about all sedative medicines you are taking and strictly follow your doctor's dosage recommendation. It may be useful to inform your friends and family about the signs and symptoms indicated above. Tell your doctor if you experience any of these symptoms.

• Medicines that can cause or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Adolonta retard 50 mg concomitantly with these medicines. Your doctor will tell you if Adolonta retard 50 mg is suitable for you.
• Medicines for the treatment of depression. Adolonta retard 50 mg can interact with these medicines, and you may experience a serotonin syndrome (see section 4 "Possible side effects").
• Coumarin anticoagulants (medicines that prevent abnormal blood clotting), such as warfarin, with Adolonta retard 50 mg. The effect of these medicines on blood clotting may be affected, and it can lead to bleeding.
• Gabapentin or pregabalin for the treatment of epilepsy or pain due to nerve problems (neuropathic pain).

Taking Adolonta retard 50 mg with food and alcohol

Do not consume alcohol during treatment with Adolonta retard 50 mg, as its effect may be intensified. Food does not affect the effect of Adolonta retard 50 mg.

Children and adolescents

Use in children with respiratory problems:

Tramadol is not recommended in children with respiratory problems, as the symptoms of tramadol toxicity can worsen in these children.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There is very little information available on the safety of tramadol in pregnant women. Therefore, you should not take Adolonta retard 50 mg if you are pregnant.

Chronic treatment during pregnancy can lead to withdrawal syndrome in newborns.

Tramadol can pass into breast milk. For this reason, you should not take Adolonta retard 50 mg more than once during breastfeeding, or, if you take it more than once, you should stop breastfeeding.

Based on human experience, it is not suggested that tramadol affects fertility in men and women.

Driving and using machines

Ask your doctor if you can drive or use machines during treatment with Adolonta retard 50 mg. It is important that before driving or using machines, you observe how this medicine affects you. Do not drive or use machines if you feel drowsy, dizzy, have blurred vision, or double vision, or have difficulty concentrating. Be especially careful at the start of treatment, after a dose increase, after a change in formulation, and/or when administered concomitantly with other medicines.

Adolonta retard 50 mg contains lactose,if your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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3. How to take ADOLONTA RETARD 50 MG

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will also explain what you can expect from the use of Adolonta retard 50 mg, when and for how long you should use it, when you should contact your doctor, and when you should stop using it (see also section 2).

The dose must be adjusted to the intensity of the pain and your individual sensitivity. Normally, the lowest possible dose that produces pain relief should be used. Do not take more than 400 mg of tramadol hydrochloride per day, unless your doctor has indicated otherwise.

Unless your doctor has given you different instructions, the recommended dose is:

Adults and adolescents over 12 years

One or two Adolonta retard 50 mg prolonged-release tablets twice a day (equivalent to 100 mg - 200 mg of tramadol hydrochloride per day), preferably in the morning and at night.

If necessary, your doctor may prescribe a different and more suitable dose of this medicine for you.

If necessary, the dose can be increased to 150 mg or 200 mg twice a day (equivalent to 300 mg - 400 mg of tramadol hydrochloride per day).

Children

Adolonta retard 50 mg is not suitable for children under 12 years.

Elderly patients

In elderly patients (over 75 years), the elimination of tramadol may be slow. If this is your case, your doctor may recommend prolonging the dosing intervals.

Patient with liver or kidney impairment/patients on dialysis

If you have severe liver or kidney disease, treatment with Adolonta retard 50 mg is not recommended. If you have moderate liver or kidney disease, your doctor may prolong the dosing intervals.

How and when should you take Adolonta retard 50 mg?

Adolonta retard 50 mg prolonged-release tablets are administered orally.

Adolonta retard 50 mg tablets should always be swallowed whole, not divided or chewed, with sufficient liquid, preferably in the morning and at night. You can take the tablet with an empty stomach or with food.

For how long should you take Adolonta retard 50 mg?

Adolonta retard 50 mg should not be administered for longer than strictly necessary.

If you require prolonged treatment, your doctor will monitor you at short and regular intervals (if necessary, with interruptions in treatment) to see if you should continue treatment with Adolonta retard 50 mg and at what dose.

If you think the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

If you take more Adolonta retard 50 mg than you should

If you have taken more Adolonta retard 50 mg than you should by mistake, it will generally not have negative effects. You should take the next dose as prescribed.

After taking very high doses, it can cause constricted pupils, vomiting, decreased blood pressure, increased heart rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), epileptic seizures, and difficulty breathing that can lead to respiratory arrest. In this case, call a doctor immediately!

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91.562.04.20, indicating the medicine and the amount taken. It is recommended to bring the medicine leaflet to the healthcare professional.

If you forget to take Adolonta retard 50 mg

If you forget to take the tablets, it is likely that the pain will return. Do not take a double dose to make up for forgotten doses, simply continue treatment as indicated by your doctor.

If you stop taking Adolonta retard 50 mg

If you stop or finish treatment with Adolonta retard 50 mg too soon, it is likely that the pain will return. If you want to stop treatment due to undesirable effects, consult your doctor.

Do not stop taking this medicine suddenly unless your doctor tells you to. If you want to stop taking your medicine, talk to your doctor first, especially if you have been taking it for a long time. Your doctor will inform you when and how to stop it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

Generally, no undesirable effects occur when finishing treatment with Adolonta retard 50 mg. However, in rare cases, when some people who have been taking Adolonta retard 50 mg for some time stop taking it suddenly, they may feel unwell. They may feel agitated, anxious, nervous, or trembly. They may feel overactive, have difficulty sleeping, or have stomach or intestinal disorders. Very few people may have panic attacks, hallucinations, unusual perceptions such as itching, tingling, and numbness, and ringing in the ears (tinnitus). Very rarely, other unusual symptoms of the central nervous system have been seen, such as confusion, delirium, distorted perception of one's own personality (depersonalization), and altered perception of reality (derealization) and delusions of persecution (paranoia). If you present any of these symptoms after stopping Adolonta retard 50 mg, please consult your doctor.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

You should consult your doctor immediately if you experience symptoms of an allergic reaction such as swelling of the face, tongue, and/or throat and/or difficulty swallowing and rash along with difficulty breathing.

The most frequent adverse effects during treatment with Adolonta retard 50 mg are nausea and dizziness, which occur in more than 1 in 10 people.

Very common: may affect more than 1 in 10 people

• Dizziness.
• Nausea.

Common: may affect 1 in 10 people

• Headache, numbness.
• Fatigue.
• Vomiting, dry mouth, constipation.
• Sweating (hyperhidrosis).

Uncommon: may affect 1 in 100 people

• Effects on the heart and blood circulation (strong heartbeats and rapid heartbeats, feeling of dizziness or collapse). These adverse effects may occur especially in patients who are incorporated or who make a physical effort.
• Desire to vomit (retching), stomach problems (e.g., feeling of pressure in the stomach, bloating), diarrhea.
• Skin reactions (e.g., itching, rash).

Rare: may affect 1 in 1,000 people

• Allergic reactions (e.g., difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure) have occurred in very rare cases.
• Slow heartbeat.
• Increased blood pressure.
• Abnormal sensations (e.g., itching, tingling, and numbness), tremors, epileptic seizures, muscle spasms, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Epileptic seizures may occur mainly after taking high doses of tramadol or when taken simultaneously with other medicines that can cause epileptic seizures.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological problems may appear after treatment with Adolonta retard 50 mg. Their intensity and nature may vary (according to the patient's personality and the duration of treatment). These problems can manifest as a change in mood (usually euphoria, occasionally irritability), changes in activity (usually decrease, occasionally increase), and decreased cognitive and sensory perception (changes in senses and recognition, which can lead to errors in judgment).
• Drug dependence may occur.
• Blurred vision, contraction of the pupils (miosis), excessive dilation of the pupils (mydriasis).
• Slow breathing, shortness of breath (dyspnea).
• A worsening of asthma has been reported; however, no causal relationship with tramadol has been established. If the recommended doses are exceeded or if it is taken concomitantly with other medicines that depress brain function, a decrease in respiratory frequency may occur.
• Muscle weakness.
• Difficulty or pain when urinating, less urine than normal (dysuria).

Very rare: may affect 1 in 10,000 people

• Increased liver enzymes.

Frequency not known: frequency that cannot be estimated from the available data

• Decrease in blood sugar levels.
• Hypo.
• Serotonin syndrome, which can manifest through changes in mental state (e.g., agitation, hallucinations, coma), and other effects, such as fever, increased heart rate, unstable blood pressure, involuntary muscle contractions, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "What you need to know before taking ADOLONTA RETARD 50 MG").

When treatment is suddenly stopped, signs of drug withdrawal syndrome may appear (see "If you stop taking Adolonta retard 50 mg").

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for human use medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of ADOLONTA RETARD 50 MG

Keep this medicine out of sight and reach of children.

Keep this medicine in a safe and protected place, where others cannot access it. This medicine can cause serious harm and even be fatal to people who have not been prescribed it.

Do not use this medicine after the expiration date that appears on the packaging after "CAD". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Adolonta retard 50 mg prolonged-release tablets

• The active ingredient is tramadol hydrochloride. Each tablet contains 50 mg of tramadol hydrochloride.
• The other components are:

Core of the tablet: microcrystalline cellulose, hypromellose 100,000 mPa·s, magnesium stearate, anhydrous colloidal silica.

Coating film: hypromellose 6 mPa·s, lactose monohydrate (see section 2 "Adolonta retard 50 mg contains lactose"), macrogol 6000, propylene glycol (E1520), talc, titanium dioxide (E171), and yellow iron oxide (E172).

Appearance of the Product and Package Contents

Adolonta retard 50 mg prolonged-release tablets are film-coated tablets of pale yellow color, round, and biconvex, marked with "T0" on one side and the manufacturer's logo ? on the other.

Adolonta retard 50 mg tablets are contained in blister strips and packaged in boxes of 10, 20, 30, 50, 60, 100, and 150 (10x15) tablets.

Only some package sizes may be marketed.

Adolonta retard 50 mg tablets are presented in packages of 10x1, 20x1, 30x1, 50x1, 60x1, 100x1, and 150x1 in precut unit-dose blisters.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36 – 28027 Madrid, Spain

Manufacturer:

Grünenthal GmbH

Zieglerstrasse, 6 – D-52078 Aachen, Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany Tramal retard 50 mg, Belgium Contramal retard 50 mg, Slovenia Tramal 50 mg, Spain Adolonta retard 50 mg

Finland Tramal retard 50 mg, Luxembourg Contramal retard 50 mg

Poland Tramal retard 50 mg

Date of the last revision of this prospectus: July 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/